Registration Dossier
Registration Dossier
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EC number: 610-461-5 | CAS number: 495-61-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38 No. 187 § 1500.42
- Version / remarks:
- 27.09.73
- Principles of method if other than guideline:
- Test substance was applied undiluted to the conjunctival sac of the right eye of 6 rabbits.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methyl-6-(4-methylcyclohex-3-en-1-ylidene)hept-2-ene
- EC Number:
- 207-805-8
- EC Name:
- 2-methyl-6-(4-methylcyclohex-3-en-1-ylidene)hept-2-ene
- Cas Number:
- 495-62-5
- Molecular formula:
- C15H24
- IUPAC Name:
- 4-(1,5-dimethylhex-4-en-1-ylidene)-1-methylcyclohexene
- Reference substance name:
- (4S)-1-methyl-4-(6-methylhepta-1,5-dien-2-yl)cyclohexene
- EC Number:
- 610-461-5
- Cas Number:
- 495-61-4
- Molecular formula:
- C15H24
- IUPAC Name:
- (4S)-1-methyl-4-(6-methylhepta-1,5-dien-2-yl)cyclohexene
- Reference substance name:
- 6-methyl-2-(4-methylcyclohex-3-enyl)hept-2,5-diene
- EC Number:
- 241-610-9
- EC Name:
- 6-methyl-2-(4-methylcyclohex-3-enyl)hept-2,5-diene
- Cas Number:
- 17627-44-0
- Molecular formula:
- C15H24
- IUPAC Name:
- 4-(1,5-dimethylhexa-1,4-dien-1-yl)-1-methylcyclohexene
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Remarks:
- Gaukler
- Details on test animals or tissues and environmental conditions:
- - Mean weight at study initiation: 2.9 kg
- Sex: 1 male, 5 females
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to DRAIZE, J.H. (1959): Dermal Toxicity. In: FDA - Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Remarks:
- mean
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- mean
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Remarks:
- mean
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Cornea, iris and conjunctival scores
| Cornea | Iris | Conjunctiva | |||||
| Readings | Animal | Opacity | Area involved | Redness | Swelling | Discharge | |
| 1h | 1 | 0 | 0 | 0 | 2 | 0 | 1 |
| 2 | 0 | 0 | 0 | 2 | 0 | 1 | |
| 3 | 0 | 0 | 0 | 2 | 0 | 1 | |
| 4 | 0 | 0 | 0 | 2 | 0 | 1 | |
| 5 | 0 | 0 | 0 | 2 | 0 | 1 | |
| 6 | 0 | 0 | 0 | 2 | 0 | 1 | |
| 24h | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 4 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 5 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 6 | 0 | 0 | 0 | 1 | 0 | 1 | |
| 48h | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 4 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 5 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 6 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 72h | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 4 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 5 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 6 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Mean (24h-72h) | 1 | 0.0 | 0.0 | 0.0 | 0.7 | 0.0 | 0.0 |
| 2 | 0.0 | 0.0 | 0.0 | 0.7 | 0.0 | 0.0 | |
| 3 | 0.0 | 0.0 | 0.0 | 1.0 | 0.0 | 0.0 | |
| 4 | 0.0 | 0.0 | 0.0 | 1.0 | 0.0 | 0.0 | |
| 5 | 0.0 | 0.0 | 0.0 | 0.3 | 0.0 | 0.0 | |
| 6 | 0.0 | 0.0 | 0.0 | 1.0 | 0.0 | 0.3 | |
| Mean (24h-72h) | all animals | 0.0 | 0.0 | 0.0 | 0.8 | 0.0 | 0.1 |
Applicant's summary and conclusion
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